1. Pink Sheet

Patent Use Codes For Brands Can Be Challenged By Generics, Supreme Court Rules

 
• By Brenda Sandburg

The high court says the Hatch-Waxman Act did not intend for one patented use of a drug to prevent the marketing of a generic for unpatented uses; Justice Sotomayor criticizes FDA for not providing clearer direction to brand manufacturers about what to include in their use codes.

The Supreme Court concluded that it simply makes sense that a generic manufacturer be able to challenge a brand company’s patent use code for incorrectly describing the patented method of using the drug.

In its unanimous April 17 ruling in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, the court...

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